Longeveron (NASDAQ:LGVN) stock is rocketing higher on Wednesday after the clinical-stage biotechnology company announced a new designation from the Food and Drug Administration (FDA). The FDA has granted Longeveron's Lomecel-B the Regenerative Medicine Advanced Therapy (RMAT) designation. This is the company's treatment for mild Alzheimer's Disease. This is big news for LGVN stockholders as it marks the first time the RMAT designation has been granted to a cellular therapeutic Alzheimer's treatment candidat ...

MIAMI, July 10, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for certain life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B™ for the treatment of mild Alzheimer's Disease. Lomecel-B™ is a proprietary, scalable, allogeneic cellular investigational therapy being ...

Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results on December 20, 2023. Full study results for CLEAR MIND will be reported in a Featured Research Oral Presentation at the 2024 Alzheimer's Association International Conference (AAIC) on July 28, 2024. The RMAT designation is the fourth special regulatory designation received by Longeveron for Lomecel-B™. The Lomecel-B™ HLHS program ...

MIAMI, July 09, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, including hypoplastic left heart syndrome (HLHS) and Alzheimer's disease, today announced that Neha Motwani, a senior healthcare investment banker, has been elected to the Longeveron Board of Directors at the Company's recent Annual Meeting of Stockholders. Neha Motwani has over 25 years ...

Neha Motwani has over 25 years of healthcare investment banking experience, most recently serving as Managing Director, Healthcare Investment Banking at William Blair. She previously held investment banking roles of increasing responsibility with Truist Securities, Oppenheimer and Company, Stifel Financial and Cowen and Company, where, collectively, she completed transactions raising approximately $7.0 billion. Ms. Motwani earned her B.A. in political science from Columbia University. Investor Contact: Dere ...

Core Insights - Longeveron Inc. has elected Dr. Roger Hajjar to its Board of Directors, enhancing its leadership in the field of gene and cell therapy [1][7] - Dr. Hajjar is recognized for his contributions to cardiac gene therapy and has initiated multiple clinical trials for cardiovascular diseases [2][4] - The company is advancing its lead product, Lomecel-B™, which has shown potential in treating conditions like hypoplastic left heart syndrome (HLHS) and Alzheimer's disease [3][5] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines to meet unmet medical needs [5] - The lead investigational product, Lomecel-B™, is an allogeneic medicinal signaling cell therapy derived from the bone marrow of young, healthy adult donors [5] - Lomecel-B™ has received significant FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for its HLHS program [5] Leadership and Strategic Direction - Dr. Hajjar's appointment is part of a planned Board refreshment process aimed at incorporating experienced leaders to enhance the company's knowledge base [7] - The company aims to leverage Dr. Hajjar's expertise to advance its therapeutic development programs, particularly in gene and cell therapy [7]

Dr. Hajjar is an internationally renowned scientific leader in the field of cardiac gene therapy. His laboratory had validated a number of cardiac targets that led to the initiation and completion under his guidance of First-inHuman gene therapy trials in patients with heart failure. He has initiated multiple clinical trials in gene therapy for a variety of cardiovascular diseases. About Longeveron Inc. Investor Contact: Derek Cole Investor Relations Advisory Solutions derek.cole@iradvisory.com "I am deligh ...

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. The Company intends to use the net proceeds from the transaction for its ongoing clinical and regulatory development of Lomecel-B™ for the treatment of several disease states and indications, including HLHS and Alzheimer's disease, obtaining regulatory approvals, capital expenditures, working capital and other general corporate purposes. This press release does not constitute an offer to sell or a solicitation of an offer to buy ...

In consideration for the immediate exercise of the existing warrants for cash and the payment of $0.125 per new warrant, the Company issued new unregistered warrants to purchase up to an aggregate of 3,395,782 shares of Class A common stock. The new warrants are immediately exercisable at an exercise price of $2.50 per share and have a term of twenty-four months from the date of issuance. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. T ...

Core Insights - Longeveron Inc. is a clinical stage biotechnology company focused on developing cellular therapies for life-threatening and chronic aging-related conditions, including hypoplastic left heart syndrome (HLHS) and Alzheimer's disease [2][4] - The company will participate in the Virtual Life Sciences Investor Forum on June 20, 2024, with a webcast available for access on their website [2][3] - Longeveron's lead investigational product, Lomecel-B™, is an allogeneic medicinal signaling cell therapy derived from the bone marrow of young, healthy adult donors, with potential applications across various disease areas [4] Company Overview - Longeveron is developing regenerative medicines to address unmet medical needs, focusing on three pipeline indications: HLHS, Alzheimer's disease, and aging-related frailty [4] - The Lomecel-B™ HLHS program has received three significant U.S. FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation [4]